Compounding Conundrums: Outsourcing Shortages, Clean Room Design, and Hazardous Drugs 2012 Midyear Clinical Meeting
|
|
- Vivian Rogers
- 6 years ago
- Views:
Transcription
1 Disclosures Patricia Kienle reports the following relevant financial relationships Employee of Cardinal Health Compounding Conundrums Outsourcing, Shortages, Clean Room Design, and Hazardous Drugs Luci Power reports the following relevant financial relationships Consultant: Intelligent Hospital Systems, S.E.A. Medical Stockholder: SEA S.E.A. Medical; Speakers Bureau: ProCE, Inc. Scientific Advisory Board member: Intelligent Hospital Systems Eric Kastango reports the following relevant financial relationships Principal and co-sponsor/co-author:2011 & 2012 USP 797 Compliance Survey, CriticalPoint, LLC President and CEO: Clinical IQ, LLC Objectives State the process to assess the appropriate use of an outsourced sterile compounding pharmacy List components of a process to assess appropriateness of a vendor new to the organization List common issues that t cause a cleanroom to fail a certification test List the concerns of occupational exposure of healthcare workers to hazardous drugs Identify NIOSH, OSHA, and accreditation organization activities in reducing hazardous drug exposure in healthcare workers Speakers Eric S. Kastango, MBA, RPh, FASHP Clinical IQ, LLC and CriticalPoint, LLC Madison, New Jersey Luci Power, MS, RPh Power Enterprises San Francisco, California Noun: co nun drum 1. A confusing and difficult problem or question 2. A question asked for amusement, typically one with a pun in its answer; a riddle Synonyms: riddle, puzzle, enigma, mystery Compounding Conundrums: Outsourcing, Shortages, and Issues with Cleanroom Design Eric Kastango, MBA, FASHP Page 1 of 11
2 Disclaimer Although I am a member of the USP Compounding Expert Committee, I am speaking today in my individual capacity and not as a member of the Committee or as a USP representative. The views and opinions presented are entirely my own. They do not necessarily reflect the views of USP, nor should they be construed as an official explanation or interpretation of <797>. Good Quality can Cost Less The focus must be on reducing waste, improving quality and not on cost-cutting initiatives. The focus must be on the patient quality and safety. If you focus on quality, the costs will take care of themselves. Improve the system, rather than working harder. In order to make major changes, you need to start by making small improvements. Requires leadership and persistence. Current push to reduce costs but not ANY costs conundrum Select low hanging fruit first but be careful of rotten fruit Are any cost reductions, valuable cost reductions? Example: Using nonsterile gloves in compounding to save 10K per year that cost reduction does NOT improve quality and potentially increases risk of contamination/ Images courtesy ClinicalIQ, LLC. Conundrums Identify organizational activities in reducing hazardous drug exposure in healthcare workers Acknowledgement Form and findings for the CriticalPoint 2011 and 2012 study data List components of a process to assess appropriateness of a vendor new to the organization Vendor qualification form and TJC Eps List common issues that cause a cleanroom to fail a certification test Using the CETA Guidelines to verify work of contractor State the process to assess the appropriate use of an outsourced sterile compounding pharmacy What to keep and what to outsource The USP 797 Compliance Study Findings Right To Know Conundrum USP Chapter <797> says: Compounding personnel of reproductive capability (male and female) shall confirm in writing that they understand the risks of handling hazardous drugs Results of CriticalPoint 2011 and 2012 Compliance Survey % of 801 locations* met this requirement % of 250 locations* met this requirement *indicated that they handled hazardous drugs Page 2 of 11
3 Right To Know Conundrum Pharmacy, Purchasing and Products Magazine published the 2011 survey article and offered the HD Risk Form for free! 6,123 people read the article Only 40 accessed the HD Risk Form This year NIOSH published a new hazardous drug list PEARL-Both are free downloads! Conundrum: What Do You Know About Them? List components of a process to assess appropriateness of a vendor new to the organization Vendor qualification form Who are you buying your non-sterile bulk APIs from? Registered with the FDA Provides of Certificate of Analysis that is specific to the lot # of drug received Are you buying drugs from the grey market/parallel market? How do ensure that the drugs have their maintained their pedigree? Is the drug a counterfeit/adulterated/misbranded item? How do you know that they [drugs] were stored properly? Conundrum: What Do You Know About Them? LD : Care, treatment, and services provided through contractual agreement are provided safety and effectively Element of Performance 1- Clinical leaders and medical staff have an opportunity to provide advice about the sources of clinical services to be provided through contractual agreement. EP 2 The hospital describes, in writing, the nature and scope of services provided through contractual agreements. EP 3 Designated leaders approve contractual agreements. EP 4 Leaders monitor contracted services by establishing expectations for the performance of contracted services. EP 5 Leaders monitor contracted services by communicating the expectations in writing to the provider of the contracted services. EP 6 Leaders monitor contracted services by evaluating these services in relation to the hospital s expectations. EP 7 Leaders take steps to improve contracted services that do not meet expectations. EP 8 When contractual agreements are negotiated or terminated, the hospital maintains the continuity of patient care. Outsourcing Conundrum Know what you are paying for by conducting a purchase cost analysis Identify top 10 drugs in volume and in dollar Decide what you what to keep and what you want to outsource Review Vendor Qualification elements with company Images courtesy ClinicalIQ, LLC. Outsourcing Conundrum What are your and your hospital s responsibilities? Do know what is in your contract? One contract detailed the following requirements: Customer shall be responsible for determining whether any compounded solution provided under this Vendor Agreement is clinically correct, appropriate or accurate for prescribing to any particular patient and for any particular disease or condition, and for determining and recording the individual patients that receive the medications Are outsourced drugs inspected upon delivery for correctness against the original order and documented? Vendor Qualification Conduct an onsite visit of operation at least annually Review the following information during audit: Have they done a gap analysis of their operation against USP 797? Results? Summary of any regulatory inspection reports from SBOP or FDA CAPA (corrective and preventive action) program, employee training records, sterility and stability data How does management ensure operational control and fitness? Observe personnel work practices and compare against vendor policy and procedure Page 3 of 11
4 Resources Outsourcing Conundrum ClinicalIQ content , ClinicalIQ, LLC all rights reserved The American Society of Health-System Pharmacists (ASHP) published an updated guidance document on outsourced compounding services in Hospital Pharmacy article: Key Considerations in Pharmacy Outsourcing: Understanding Risks and Managing Liability. Hosp Pharm. 2012;47(2): ASHP Foundation, with sponsorship from PharMEDium Services, LLC, published an electronic tool titled, Outsourcing Sterile Products Preparation: Contractor Assessment Tool CriticalPoint, LLC USP 797 Gap Analysis Tool LDT Health Solutions Automated USP <797> GAP Tool Reflection Point Certifier Conundrum Doveryai, no proveryai Trust but verify Former President Ronald Reagan cer ti fy (sûrt-f)v. cer ti fied, cer ti fy ing, cer ti fies 1. a. To confirm formally as true, accurate, or genuine b. To guarantee as meeting a standard: butter that was certified Grade A. See Synonyms at approve 2. To acknowledge in writing on the face of (a check) that the signature of the maker is genuine and that there are sufficient funds on deposit for its payment 3. To issue a license or certificate to 4. To declare to be in need of psychiatric treatment or confinement 5. Archaic To inform positively; assure Facility Requirements ISO Class 5 devices Certifier Conundrum Require every 6 month certification BSC/CACI required for hazardous drug preparation ISO Class 7 & 8 environments (buffer and ante area) Required every 6 months certification Negative-pressure required for hazardous drugs Controlled Environment Testing Association (CETA) is an organization providing guidance for certifiers Properly Tested and Certified Facility Images courtesy ClinicalIQ, LLC Page 4 of 11
5 Conundrum: What Does the Report Say? Do you know how to read your certification report? SO: Who read their last report? Common failure issues The pressure differentials are too high, low or are in the wrong direction! The tests are done at-rest and not dynamic per the chapter Ultimate responsibility for assuring engineering controls lies with institution More than just a sticker Interaction with certifier, dynamic testing Images courtesy ClinicalIQ, LLC. Properly Tested and Certified Facility Certification reference material Controlled Environment Testing Association (CETA) CETA has established an application guides (CAG ) detailing procedures for certification of sterile compounding facilities Ask for a Registered Cleanroom Certification Professional for Sterile Compounding Facilities Choosing a Certification Professional to Evaluate Your Cleanroom and Engineering Control, James T. Wagner. Published in Pharmacy, Purchasing and Products Magazine ( "Each problem that I solved became a rule which served afterwards to solve other problems." - Rene Descartes ( ), "Discours de la Methode" My contact information: Eric S. Kastango, MBA, RPh, FASHP Clinical IQ, LLC 235 Main Street, Ste 292 Madison, NJ eric.kastango@clinicaliq.com Compounding Conundrums: Hazardous Drugs Luci A Power, BS, MS Handling Hazardous Drugs: What are We Worried About? Acute exposure Hazardous Drug (HD) uptake Reproductive risks Long term exposure: cancer? Page 5 of 11
6 Acute Exposure Anecdotal reports of drug contact with exposed skin, eyes, etc. due to spills or mishaps Exposure due to cuts or needle sticks HD Uptake HD uptake into workers has been shown to occur when work areas have surface contamination with HD residue 1999 study 3 drugs measured in 6 hospitals: 75% of the pharmacy wipes & 65% of the nursing wipes were contaminated HD Residue 2010 study 5 drugs measured in 3 hospitals: 75% of fthe pharmacy wipes & 43% of the nursing wipes were contaminated Connor TH. AJHP 7/1999; Connor TH. JOEM 10/2010 HD Compounding: Surface Contamination Work area of BSC IV bags Counter tops Storage bins Waste containers Photo courtesy of TH Connor co nun drum Despite promotion of awareness of HD exposure; new guidelines from ; and extensive marketing of new devices for improved safety NO MEASURABLE IMPROVEMENT HD Uptake biomarker studies and 12 drug in urine studies since 1979 were reviewed 45% of biomarkers were positive 83% of urine samples were positive Baker ES. Connor TH. AJHP 11/1996 Page 6 of 11
7 Reproductive Risks of Working with HD 2005 meta-analysis of studies found increased risk of spontaneous abortion 2012 study of nurses exposed from 1989 found 2-fold increased risk of spontaneous abortion co nun drum Although HDs are known reproductive hazards, US nurses are still reporting exposures to these during pregnancy Dranitsaris G. JOPP 2005 Lawson CC. AmJObGyn 4/2012 Long Term Risks 2010 Study describes evidence of drug uptake and chromosomal changes in oncology workers Chromosomes 5 and 7 were affected as in t-aml after alkylating agent treatment co nun drum Why isn t somebody doing something? McDiarmid MA. JOEM 10/2010 NIOSH Activities In 2011, senior officials of NIOSH, OSHA, and TJC collaborated on a letter that was sent to all hospital employers in the United States stating that hazardous drugs can pose serious job-related health risks to workers if proper precautions are not used in handling the drugs 2004 Alert on Preventing HD Occupational Exposures Research activity including 2010 studies of worker contamination; chromosomal abnormalities; and occupational exposures among nurses Page 7 of 11
8 NIOSH Topics Pages Occupational Exposure To Antineoplastic Agents Hazardous Drug Exposures In Health Care NIOSH HD List Update of HD list based on new drug approvals by the FDA and new warnings on existing drugs posted by the FDA Initial review by internal committee and review by peer reviewers and stakeholders List submitted for public comment OSHA OSHA has no standard for exposure to HD but has generated 3 guidelines 1986, 1995, 1999 Controlling occupational exposure to hazardous drugs. In: OSHA Technical Manual, TED A, Sec VI, Chap II: _vi_2.html OSHA The Occupational Safety and Health Act is administered by OSHA Employers subject to the OSH Act have a general duty to provide work and a workplace free from recognized, serious hazards OSHA - HazCom Hazard Communication Standard 29 C.F.R. part Revised 2012 Safety Data Sheet (SDS) Requires training programs and worker protection Defines hazardous chemicals and health hazards The Joint Commission Standard EC.3.10 The organization manages its hazardous materials and waste risks. Rationale for EC.3.10 Organizations must identify materials they use that need special handling and implement processes to minimize the risks of their unsafe use and improper disposal Page 8 of 11
9 co nun drum Whose job is it to promote safety? co nun drum? HD Pearls PEARLS!!! Start work practices with RECEIVING Cartons may arrive broken There is drug residue on outside of vials and on packaging Totes Should be Labeled + Vials Wrapped HD Pearls Receiving staff must be trained to handle broken packages and have access to spill kits Page 9 of 11
10 Good Work Practices Bag Vials for Transport Use gloves and bags! Place disposable liner on surfaces Wipe Down HD Vials Spray the wiper, not the vial Spraying the vial may move HD residue to other items or areas Use wet wipes Poor HD Technique Generated with compounding in BSC or CACI Need better work practices HD Residue? Magic Boxes? Neither BSC nor CACI provide complete containment of HD residue! Photos courtesy of TH Connor Photos courtesy of NuAire, Inc. Page 10 of 11
11 HD Residue? Reaching out of BSC drops drug residue Residue may come from isolator pass throughs CACI photo courtesy of NuAire, Inc Transfer of HD Residue Gloves get contaminated Don and remove gloves carefully Don t touch anything! Sanitize HD gloves with wipes not spray Transfer of HD Residue Gowns have been shown to be contaminated Saving and reusing gowns may result in drug transfer co nun drum Patient safety or MY safety? Conclusion Questions? Change requires a focus on safety, not occupational safety or patient safety, but just safety. Gerald Goodman, Dr.P.H. Texas Woman s University Goodman GR. Nurs Econ Jan/Feb 2004 Page 11 of 11
Clinical IQ, LLC September 2, 2009
The Top 10 Gaps in USP 797 Compliance Eric S. Kastango, MBA, RPH, FASHP Clinical IQ, LLC September 2, 2009 eric.kastango@clinicaliq.com Disclaimer Although I am a member of the USP Sterile Compounding
More informationAdvanced Sterile Product Preparation Training and Certificate Program
Advanced Sterile Product Preparation Training and Certificate Program ACPE Activity Number(s): 0204-0000-16-725-H04-P & T thru to 0204-0000-16-733-H04-P & T Release Date: November 7, 2016 Expiration Date:
More informationEnsuring Healthcare Worker Safety When Handling Hazardous Drugs: The Joint Position Statement From the Oncology Nursing Society, the American
Ensuring Healthcare Worker Safety When Handling Hazardous Drugs: The Joint Position Statement From the Oncology Nursing Society, the American Society of Clinical Oncology, and the Hematology/Oncology Pharmacy
More informationPreventing Occupational Exposure to Hazardous Drugs
Preventing Occupational Exposure to Hazardous Drugs Teresa (Terry) Fisk, CIH, CSP, Non-Clinical Loss Control Director, IRMS, Trinity Health fiskt@trinity-health.org 734-343-0907 April 12, 2017 Introduction
More informationImplementing USP
Implementing USP 800 Joanna Robinson, PharmD, MS Inpatient Operations Manager Disclosure I have no conflicts of interest to disclose Objectives 1. Understand the purpose of USP 80 2. Describe how to engage
More informationImplementing USP 800 ASHLEY DUTY, PHARMD, MS JOANNA ROBINSON, PHARMD, MS
Implementing USP 800 ASHLEY DUTY, PHARMD, MS JOANNA ROBINSON, PHARMD, MS Disclosure Ashley Duty has no conflicts of interest to disclose Joanna Robinson has no conflicts of interest to disclose Objectives
More informationImplementing USP 800 ASHLEY DUTY, PHARMD, MS JOANNA ROBINSON, PHARMD, MS
Implementing USP 800 ASHLEY DUTY, PHARMD, MS JOANNA ROBINSON, PHARMD, MS Disclosure Ashley Duty has no conflicts of interest to disclose Joanna Robinson has no conflicts of interest to disclose Objectives
More informationSterile Compounding of Hazardous Drugs
Sterile Compounding of Hazardous Drugs Session II Pamella Ochoa, Pharm.D. Jose Vega, Pharm.D. 2 Objectives List requirements of secondary engineering controls for hazardous compounding Explain requirements
More informationCompounded Sterile Preparations Pharmacy Content Outline May 2018
Compounded Sterile Preparations Pharmacy Content Outline May 2018 The following domains, tasks, and knowledge statements were identified and validated through a role delineation study. The proportion of
More informationLeveraging Nursing Expertise with USP<800>
Leveraging Nursing Expertise with USP Martha Polovich, PhD, RN, AOCN Assistant Professor Byrdine F. Lewis College Of Nursing And Health Professions Disclosure Martha Polovich served as: A volunteer
More informationSterile Compounding: Highlights of the New Law
Patricia C. Kienle, RPh, MPA, FASHP Director, Accreditation and Medication Safety Cardinal Health Innovative Delivery Solutions Sterile Compounding: Highlights of the New Law 2 Please explain the difference
More informationThe Leader in Guidance for the Health Information Management Profession. Patient Safety Monitor Journal
The Leader in Guidance for the Health Information Management Profession Patient Safety Monitor Journal Volume 18 Issue No. 1 January 2017 USP : Protecting healthcare workers from hazardous drugs According
More informationIntroduction to USP General Chapter <800> How Will It Affect Federal Pharmacy?
CPE Information and Disclosures Introduction to USP General Chapter How Will It Affect Federal Pharmacy? MAJ Jonathan Bartlett Moncrief Army Health Clinic CPT(P) Seth Mayer Walter Reed National Military
More informationADMINISTRATIVE CONTROLS FOR MANAGING HAZARDOUS DRUGS
ADMINISTRATIVE CONTROLS FOR MANAGING HAZARDOUS DRUGS TECHNICAL INFORMATION PAPER NO. 56-073-0417 PURPOSE This paper describes several administrative controls for the safe handling of hazardous drugs (HD):
More informationThe Joint Commission Medication Compounding Certification (MDC) FAQs
The Joint Commission will be implementing the new Medication Compounding Certification (MDC) program for hospitals, critical access hospitals, and home care pharmacy organizations in the state of Michigan
More information4/18/2018. Improving USP <800> Compliance in a Community Healthcare Organization. Disclosures. Learning Objectives
Improving USP Compliance in a Community Healthcare Organization Brady Conner, Pharm.D. PGY1 Pharmacy Resident St. Vincent Healthcare, Billings, MT 4/20/1018 Disclosures IRB Status: Exempt Co-investigators
More information2018 Pharmacy Education Series
2018 Pharmacy Education Series February 21, 2018 2018 Joint Commission Update Featured Speakers: Patricia C. Kienle, RPh, MPA, FASHP Director, Accreditation & Medication Safety Cardinal Health Innovative
More informationLaboratory Chemical Hygiene Plan Research Lab
Laboratory Chemical Hygiene Plan Research Lab A chemical hygiene plan is a written program developed to establish procedures, protective equipment requirements and standard work practices that promote
More informationUnderstanding USP 797
Baxa Corporation Understanding USP 797 Technical Paper An Overview of USP General Chapter Pharmaceutical Compounding Sterile Preparations Mike Hurst, RPh, MBA 2004 Baxa Corporation Introduction USP
More informationThis course was written for RN.ORG by an outside consultant and RN.ORG has rights for distribution but is not responsible for the contents.
Safe Handling of Hazardous Drugs WWW.RN.ORG Reviewed September 2017, Expires September 2019 Provider Information and Specifics available on our Website Unauthorized Distribution Prohibited 2017 RN.ORG,
More informationLaboratory Chemical Hygiene Plan -- Teaching Lab
Laboratory Chemical Hygiene Plan -- Teaching Lab A chemical hygiene plan is a written program developed to establish procedures, protective equipment requirements and standard work practices that promote
More informationExtract from Managing Infection Control
TOPIC ONE: CONDUCTING AN INFECTION CONTROL RISK AUDIT The aims and objectives of this topic are to: state the rationale for conducting a risk audit detail the occasions when a risk audit should be conducted
More informationPharmacy Sterile Compounding Areas
Approved by: Pharmacy Sterile Compounding Areas Corporate Director, Environmental Supports Environmental Services/ Nutrition Food Services Operating Standards Manual Number: Date Approved June 17, 2016
More informationBloodborne Pathogens Cumru Township Fire Department 02/10/2011 Policy 10.5 Page: 1 of 7
Policy 10.5 Page: 1 of 7 Purpose: The Cumru Township Fire Department is committed to providing a safe and healthful work environment for our entire staff, both career and volunteers. In pursuit of this
More informationAbout OMICS Group Conferences
About OMICS Group OMICS Group International is an amalgamation of Open Access publications and worldwide international science conferences and events. Established in the year 2007 with the sole aim of
More information11/4/2016. Sterile Compounding: USP<797> Revisions and the Compounding Quality Act. In the 1930 s and 40 s, 60% of all medications were compounded.
Sterile : USP Revisions and the Quality Act Joe Haynes, RPh, CPh, MBA Lead Sterile Products Pharmacist Johns Hopkins All Children s Hospital Objectives: Disclosure: I have no financial interests to
More informationPHARMACY SERVICES / MEDICATION USE
25.01.02 Supervision of Pharmacy Activities. In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice consistent
More informationOverview. Diane Cousins, R.Ph U.S. Pharmacopeia. 1 Pharmacy Labeling with Color
As more medications are approved and become available to Americans, the opportunity for potentially dangerous or even deadly errors due to drug mix-ups from look alike or sound alike names becomes increasingly
More informationUSP <800>: Navigating the New Requirements for Handling Hazardous Drugs in the Community Oncology Setting
USP : Navigating the New Requirements for Handling Hazardous Drugs in the Community Oncology Setting Exploratory Paper Nina K. Chavez, MBA, SPHR, FACMPE August 22, 2017 This paper is being submitted
More informationAdministration OCCUPATIONAL HEALTH AND SAFETY
ACCREDITATION STANDA RDS OCCUPATIONAL HEALTH AND SAFETY The accreditation standards relating to occupational health and safety include those most critical to staff safety in the non-hospital setting; however,
More informationHazard Communication. OSHA Office of Training and Education 1
Hazard Communication OSHA Office of Training and Education 1 Introduction About 32 million workers work with and are potentially exposed to one or more chemical hazards There are approximately 650,000
More informationSafety in the Pharmacy
Safety in the Pharmacy Course Practicum in Health Science - Pharmacology Unit I Preparation for Practicum Essential Question Why is safety in the pharmacy important not only to the patient, but the pharmacy
More informationSafe Handling of Hazardous Drugs to Protect Healthcare Workers
41 Safe Handling of Hazardous Drugs to Protect Situation Healthcare personnel who transport, prepare, administer, and dispose of hazardous drugs can be exposed to these toxic agents in the air or on work
More informationSARASOTA MEMORIAL HOSPITAL
SARASOTA MEMORIAL HOSPITAL TITLE: NURSING PROCEDURE HANDLING LIQUID CHEMOTHERAPY SPILLS DATE: REVIEWED: PAGES: 03/86 11/17 1 of 6 PS1094 ISSUED FOR: Nursing RESPONSIBILITY: RN PURPOSE: OBJECTIVE: KNOWLEDGE
More information320- HAZARD COMMUNICATION
320.1 PURPOSE A. To ensure the safe use of hazardous chemicals and to comply with the requirements of OSHA 1910.1200. 320.2 SCOPE A. This program is applicable to all CNM employees who may be exposed to
More informationHealth And Safety Instructions On Cleaning >>>CLICK HERE<<<
Health And Safety Instructions On Cleaning Materials At Home Identify the risks involved with window cleaning, choose the right access equipment to do the job. Vaccine Safety Guidelines for Flu Vaccination
More informationPersonal Protective Equipment Program. Risk Management Services
Personal Protective Equipment Program Services Table of Contents I. Program Goals and Objectives... 2 II. Scope and Application... 2 III. Responsibilities... 2 IV. Procedures... 3 V. Training... 5 VI.
More informationVeterinary. Hazardous Drug Program Guide
This guide, developed by DOSH staff, has been reviewed by hazardous drug stakeholders, and is advisory in nature, informational in content, and intended to assist employers in providing a safe and healthful
More informationSurface Contamination
Processes to Address Surface Contamination A Midday Symposium and Live Webinar conducted at the 52nd ASHP Midyear Clinical Meeting and Exhibition Monday, December 4, 2017 11:30 a.m. 1:00 p.m. Orlando,
More information1.0 Sterile Compounding Personnel
Print Version - ASHP Self-Assessment Tool for Compounding Sterile Preparations Thank you for participating in the ASHP Self-Assessment Tool for determining compliance with USP Chapter requirements.
More informationManhattan Fire Protection District
SOP #: 102-1 Effective Date: 04/02/11 Revised Date: 06/13/016 Section: Administraton Subject: Infection/Exposure Control PURPOSE: The purpose of this SOP is to establish an Infection Control Policy for
More informationHazardous Materials and Waste Management Plan
Hazardous Materials and Waste Management Plan EC 01.01.01 EP 5; EC 02.02.01; EC 04.01.01 I PURPOSE MCG Health, Inc. (MCGHI) is a leader in health care for the state of Georgia and provides a full spectrum
More informationHazardous Drugs. Controlling the risk in healthcare facilities. By Joseph W. Klancher, Mary Vorndran and William Weiss
Occupational Hazards Occupational Hazards Hazardous Drugs Controlling the risk in healthcare facilities By Joseph W. Klancher, Mary Vorndran and William Weiss Joseph W. Klancher, M.P.H., CSP, is a safety
More informationTEXAS HAZARD COMMUNICATION ACT AND RULES. Sec : EMPLOYEE EDUCATION PROGRAM
TEXAS HAZARD COMMUNICATION ACT AND RULES Sec. 502.010: EMPLOYEE EDUCATION PROGRAM (a) An employer shall provide at least once a year, an education and training program for employees. INTRODUCTION The Texas
More informationAssessment of safe antineoplastic drug handling practices in community pharmacies, veterinary settings and long-term care homes in Ontario.
Assessment of safe antineoplastic drug handling practices in community pharmacies, veterinary settings and long-term care homes in Ontario. Sheila Kalenge 1,2 Chun-Yip Hon 3 Kathy Vu 2,4 Henrietta Van
More information6/23/2011. Compounded Sterile Products Update and Review. Learning Goals for the Pharmacist. Learning Goals for the Pharmacy Technician
Compounded Sterile Products- 2011 Update and Review Jo Ann Gibbs, PharmD Director of Pharmacy Byrd Regional Hospital Leesville, LA Learning Goals for the Pharmacist The pharmacist will be able to: 1. Identify
More informationUSP 797: A FOCUS ON ANTIMICROBIAL RISK LEVEL KAREN MILKIEWICZ, PHARMD
USP 797: A FOCUS ON ANTIMICROBIAL RISK LEVEL KAREN MILKIEWICZ, PHARMD USP 797: A FOCUS ON ANTIMICROBIAL RISK LEVEL ACTIVITY DESCRIPTION On June 1, 2008, The Revision Bulletin to USP Chapter 797, Pharmaceutical
More informationHAZARDOUS DRUGS: HANDLING PRECAUTIONS BACKGROUND PURPOSE POLICY STATEMENTS
BACKGROUND Hazardous drugs are drugs that pose a potential health risk to workers who may be exposed to them during receipt, transport, preparation, administration, or disposal. These drugs require special
More informationProcedure: 3.4.1p4. (II. D. 4.) Hazard Communication Program Planning and Hazardous Material Inventory
Procedure: 3.4.1p4. (II. D. 4.) Hazard Communication Program Planning and Hazardous Material Inventory Revised: January 17, 2017; November 7, 2013 Last Reviewed: January 17, 2017; October 14, 2016 Adopted:
More informationInfection Control in the Hearing Aid Clinic What is infection control & why should we care?
Infection Control in the Hearing Aid Clinic What is infection control & why should we care? OBJECTIVES What do we need to do? A.U. Bankaitis, PhD, FAAA Vice President & General Manager Oaktree Products,
More informationINFECTION CONTROL SURVEYOR WORKSHEET
Attachment 2 Exhibit 351 INFECTION CONTROL SURVEYOR WORKSHEET Instructions: The following is a list of items that must be assessed during the on-site survey, in order to determine compliance with the infection
More information2017 Pharmacy Education Series
2017 Pharmacy Education Series March 15, 2017 2017 Joint Commission Update Featured Speakers: Patricia C. Kienle, RPh, MPA, FASHP Terry Baughman Kathryn E. DeSear, PharmD, BCPS, AAHIVP Online Evaluation,
More informationRULES OF THE TENNESSEE BOARD OF PHARMACY CHAPTER STERILE PRODUCT PREPARATION IN PHARMACY PRACTICE TABLE OF CONTENTS
RULES OF THE TENNESSEE BOARD OF PHARMACY CHAPTER 1140-07 STERILE PRODUCT PREPARATION IN PHARMACY PRACTICE TABLE OF CONTENTS 1140-07-.01 Applicability 1140-07-.05 Labeling 1140-07-.02 Standards 1140-07-.06
More informationONCOLOGY PRACTICE MANAGEMENT
ONCOLOGY PRACTICE MANAGEMENT Christopher A. Fausel, Pharm.D., MHA, BCOP Clinical Manager, Oncology Pharmacy Chair, Hoosier Cancer Research Network Indiana University Simon Cancer Center Indianapolis, Indiana
More informationBLOODBORNE PATHOGENS
BLOODBORNE PATHOGENS Supplement to Standard Training Module TRAINING REQUIREMENTS OVERVIEW This standard Vivid training module provides a general overview of Bloodborne Pathogens (BBP). It is important
More informationSOCCCD. Bloodborne Pathogens Exposure Control Program
SOCCCD Bloodborne Pathogens Exposure Control Program Office of Risk Management District Business Services Revised: 06/07/2016 Updated: 07/31/2017 SOUTH ORANGE COUNTY COMMUNITY COLLEGE DISTRICT BLOODBORNE
More informationC DRUG DISTRIBUTION SYSTEMS
C DRUG DISTRIBUTION SYSTEMS JANET HARDING ORAL MEDICATION SYSTEMS Hospital pharmacy departments are expected to operate drug distribution systems which are safe for the patient, efficient and economical,
More informationRadiopharmaceutical. Qualification. Checklist
Radiopharmaceutical Vendor Qualification Checklist section 1: RegulatoRy compliance Overview Nuclear pharmacies play an essential role in the preparation and distribution of radiopharmaceuticals for use
More informationATTACHMENT B: TCSG Exposure Control Plan Model INTRODUCTION
ATTACHMENT B: TCSG Exposure Control Plan Model 2016-2017 INTRODUCTION Oconee Fall Line Technical College Exposure Control Plan for Occupational Exposure to Bloodborne Pathogens and Airborne Pathogens/Tuberculosis
More informationFormaldehyde Exposure Control Policy
Formaldehyde Exposure Control Policy POLICY AND PROCEDURES FOR WORKING WITH FORMALDEHYDE Policy: It is Columbia University (CU) policy to maintain formaldehyde exposure below the action level (AL) 0.5
More informationSCOPE PURPOSE. BACKGROUND and DEFINITIONS
POLICIES/PROCEDURES TITLE: Safe Handling of Hazardous Medications SCOPE All pharmacy and nursing staff must have proper knowledge and training in handling techniques for hazardous medications as described
More informationCORPORATE SAFETY MANUAL
CORPORATE SAFETY MANUAL Procedure No. 27-0 Revision: Date: May 2005 Total Pages: 9 PURPOSE To make certain that our employees are duly aware of the hazards of blood exposure or other potentially infectious
More informationEXPOSURE CONTROL PLAN
BLOODBORNE PATHOGEN EXPOSURE CONTROL PLAN SALT LAKE COMMUNITY COLLEGE October 2011 ~ 1 ~ POLICY Salt Lake Community College is committed to providing a safe and healthful work environment for our entire
More informationENDORSED BY THE GOVERNANCE COMMITTEE
Guideline for Expectant Mothers and those trying to conceive involved in the administration of and/or the care of patients receiving chemotherapy/monoclonal antibodies Version History Version Date Brief
More informationJeanne Moldenhauer (c) Jeanne Moldenhauer
Jeanne Moldenhauer (c) Jeanne Moldenhauer 2013 1 Presentation Overview Conflicts between regulatory and compendial guidance Understanding the requirements for non sterile and terminally sterilized products
More informationCreating An Effective OSHA Compliance Program
Presents Creating An Effective OSHA Compliance Program Bloodborne Pathogens and Your Course Faculty R. Thomas (Tom) Loughrey, MBA, CCS-P Chairman, CEO & Co-Founder of Economedix Certified Coding Specialist
More informationShawnee State University
Shawnee State University AREA: ACADEMIC AFFAIRS POLICY NO.: 5.21 ADMIN. CODE: 3362-5-22 PAGE NO.: 1 OF 13 EFFECTIVE DATE: 6 / 1 8 / 9 3 RECOMMENDED BY: A.L. Addington SUBJECT: BLOODBORNE PATHOGENS APPROVED
More informationFormaldehyde Exposure Control Plan
A. Purpose To maintain formaldehyde exposure below the limits established by the Occupational Safety and Health Administration s (OSHA) Formaldehyde Standard 29 CFR 1910.1048. These limits are the Action
More informationMEDICAL WASTE MANAGEMENT PLAN
Merced County Department of Public Health Division of Environmental Health 260 E.15th Street Merced, CA 95341-6216 Phone: (209) 381-1100 Fax: (209) 384-1593 www.countyofmerced.com/eh MEDICAL WASTE MANAGEMENT
More informationSafe Storage of Hazardous Chemicals Policy
Safe Storage of Hazardous Chemicals Policy By maximising responsiveness of the prospective hazards of chemicals and equipment, we condense the risk of harm to educators, children and families by ensuring
More informationPolicies and Procedures. RNSP: RN Procedure. I.D. Number: 1067
Policies and Procedures RNSP: RN Procedure Title: CHEMOTHERAPY BLADDER INSTILLATION (INTRAVESICAL) CARE OF CLIENT I.D. Number: 1067 Authorization: [] SHR Nursing Practice Committee Source: Nursing Date
More informationD DRUG DISTRIBUTION SYSTEMS
D DRUG DISTRIBUTION SYSTEMS JANET HARDING ORAL MEDICATION SYSTEMS Drug distribution systems in the hospital setting should ideally prevent medication errors from occurring. When errors do occur, the system
More informationMSAD 55. Blood Borne Pathogens Control Plan. 137 South Hiram Road Hiram, Maine (207)
MSAD 55 Blood Borne Pathogens Control Plan 137 South Hiram Road Hiram, Maine 04041 www.sad55.org (207) 625-2490 MSAD 55 BLOOD BORNE PATHOGENS EXPOSURE CONTROL PLAN 1 PURPOSE In accordance with the OSHA
More informationUSP <797>: Making the Case for Increasing Environmental Controls in Pharmaceutical Compounding. By Eric S. Kastango, M.B.A., R.Ph.
USP : Making the Case for Increasing Environmental Controls in Pharmaceutical Compounding By Eric S. Kastango, M.B.A., R.Ph., FASHP SUPPORTED BY AN UNRESTRICTED EDUCATIONAL GRANT FROM HOSPIRA, INC.
More informationImproving Sterile Compounding: Impact of New Regulations, Standards and Guidelines PharMEDium Lunch and Learn Series LUNCH AND LEARN
LUNCH AND LEARN Improving Sterile Compounding: Impact of New Regulations, Standards and Guidelines September 9, 2016 Featured Speaker: Darryl S. Rich, PharmD, MBA, FASHP Medication Safety Specialist Institute
More informationSALEM TOWNSHIP FIRE DEPARTMENT BLOODBORNE EXPOSURE CONTROL PLAN
PURPOSE SALEM TOWNSHIP FIRE DEPARTMENT BLOODBORNE EXPOSURE CONTROL PLAN The Salem Township Fire Department (STFD) is committed to providing a safe and healthful work environment for our entire staff. The
More informationCertified Healthcare Safety Environmental Services (CHS-EVS) Examination Blueprint/Outline
Certified Healthcare Safety Environmental Services (CHS-EVS) Examination Blueprint/Outline Exam Domains 100-130 1. Safety Management 38-50 (38%) 2. Hazard Control 38-50 (38%) 3. Compliance & Voluntary
More informationCASE STUDY: PENINSULA REGIONAL MEDICAL CENTER
CASE STUDY: PENINSULA REGIONAL MEDICAL CENTER Incorporating IV room efficiencies while striving toward improving patient care 111852 2K 01/13 Page 1 of 5 OVERVIEW Peninsula Regional Medical Center (PRMC),
More informationWRITTEN HAZARD COMMUNICATION PROGRAM. Prepared for: BORO OF
Prepared for: BORO OF 2013 TABLE OF CONTENTS INTRODUCTION...1 POLICY:...1 OBJECTIVE:...1 PURPOSE:...1 RESPONSIBLE PERSONS:...2 HAZARD DETERMINATION...3 PHYSICAL HAZARDS:...3 HEALTH HAZARDS:...4 EXEMPT
More informationGuidance for the Selection and Use of Personal Protective Equipment (PPE) in Healthcare Settings
Guidance for the Selection and Use of Personal Protective Equipment (PPE) in Healthcare Settings : Program Goal Improve personnel safety in the healthcare environment through appropriate use of PPE. :
More informationPROMOTING BEST PRACTICES FOR THE SAFE HANDLING OF HAZARDOUS DRUGS A CONTINUING EDUCATION WEBINAR
PROMOTING BEST PRACTICES FOR THE SAFE HANDLING OF HAZARDOUS DRUGS A CONTINUING EDUCATION WEBINAR PROMOTING BEST PRACTICES FOR THE SAFE HANDLING OF HAZARDOUS DRUGS Firouzan Fred Massoomi, PharmD, FASHP
More informationCertified Hazard Control Manager (CHCM) Certified Hazard Control Manager Security (CHCM-SEC) Examination Blueprint/Outline
Certified Hazard Control Manager (CHCM) Certified Hazard Control Manager Security (CHCM-SEC) Examination Blueprint/Outline (Effective October 1, 2017) Exam Domains 145 Items 1. Safety Management 43 Items/30%
More informationOSHA Preparedness. Presented by: Dave Lall, CEO, DEMILEC (USA) LLC
OSHA Preparedness Presented by: Dave Lall, CEO, DEMILEC (USA) LLC Safety Manual A Safety Manual is not required by OSHA, but a Written Respiratory Protection Program is. It is much easier to incorporate
More informationLUNCH AND LEARN. Proposed USP 800 Safely Handling Hazardous Drugs August 8, 2014
LUNCH AND LEARN Proposed USP 800 Safely Handling Hazardous Drugs August 8, 2014 Featured Speaker: Firouzan 'Fred' Massoomi, Pharm.D., FASHP Pharmacy Operations Coordinator, Department of Pharmacy Services
More informationCHEMICAL HYGIENE PLAN
CHEMICAL HYGIENE PLAN The SDSU Laboratory Chemical Safety Program for Compliance with 29 CFR 1910.1450 and 8 CCR 5191: Occupational Exposure to Hazardous Chemical in Laboratories Prepared by San Diego
More informationBloodborne Pathogens. Goal. Objectives. Background
Texas Department of Insurance Division of Workers Compensation Safety Education and Training Programs Bloodborne Pathogens Goal HS99-152C(2-05) Definitions This program provides information about the requirements
More informationEnvironmental Health and Safety Department & Chemical Hygiene. Respiratory Protection Program
1 Environmental Health and Safety Department & Chemical Hygiene Respiratory Protection Program INTRODUCTION The primary objective of Harkwick College occupational health program is the prevention of adverse
More informationControl Practices for. Mary McGoldrick, MS, RN, CRNI
Essential Infection Control Practices for Home Infusion Nurses Mary McGoldrick, MS, RN, CRNI Top 5 Things to Know for CE: Make sure your BADGE IS SCANNED each time you enter a session, to record your attendance.
More informationCAPE ELIZABETH SCHOOL DEPARTMENT Cape Elizabeth, Maine
In accordance with OSHA Bloodborne Pathogens standards, 29 CFR 1910.1030, the following exposure control plan has been developed. 1. EXPOSURE DETERMINATION The purpose of this plan is to limit occupational
More information1.2 billion ambulatory care visits in US: physician offices, outpatient hospital and ED
Overview More patients obtain healthcare in specialty clinics and physicians offices in the United States than in hospitals 1.2 billion ambulatory care visits in US: physician offices, outpatient hospital
More informationBloodborne Pathogens & Exposure Control Plan
Bloodborne Pathogens & Exposure Control Plan Rev. 9/8/16 Page 1 of 8 Purpose: To ensure that Wayne County employees are aware and trained in bloodborne pathogens to eliminate and minimize employee exposure
More informationAppendix AX: B Occupational Exposure to Bloodborne Pathogens Exposure Control Plan
Occupational Exposure to Bloodborne Pathogens Exposure Control Plan Employer: Nevada State Health Division Effective Date: May 5, 1992 Compliance Statement: In accordance with OSHA Bloodborne Pathogens
More informationCHEMOTHERAPY/HAZARDOUS DRUGS PRECAUTIONS, PREPARATION, ORDERING
CHEMOTHERAPY/HAZARDOUS DRUGS PRECAUTIONS, PREPARATION, ORDERING Naser Z. Alsharif, PharmD, PhD Professor, School of Pharmacy and Health Profeesions Creighton University, Omaha, NE Selected Slides Courtesy
More informationASHP Guidelines on Outsourcing Pharmaceutical Services
ASHP Guidelines on Outsourcing Pharmaceutical Services Pharmacy Management Guidelines 473 Purpose Health-system pharmacy, as an essential component in health care organizations, is challenged by changes
More informationAmbulatory Surgical Center (ASC) INFECTION CONTROL SURVEYOR WORKSHEET
Ambulatory Surgical Center (ASC) INFECTION CONTROL SURVEYOR WORKSHEET Name of State Agency or AO (please print at right): HFAP Instructions: The following is a list of items that must be assessed during
More informationHouston Controls, Inc Safety Management System
Preparation: Safety Mgr Authority: Dennis Johnston Issuing Dept: Safety Page: Page 1 of 8 Purpose This Bloodborne Pathogen Exposure Control Plan has been established to ensure a safe and healthful working
More informationSJN DO CB Field Alert Reports. Edwin Ramos Director of Compliance Food and Drug Administration San Juan District Office
SJN DO CB Field Alert Reports Edwin Ramos Director of Compliance Food and Drug Administration San Juan District Office SJN DO Mission Assuring that safe and effective drugs are available to the public
More informationBLOODBORNE PATHOGENS EXPOSURE PREVENTION POLICY AND PROCEDURE BLOODBORNE PATHOGENS EXPOSURE CONTROL PLAN
BLOODBORNE PATHOGENS EXPOSURE PREVENTION POLICY AND PROCEDURE This sample plan is provided only as a guide to assist in complying with the OSHA Bloodborne Pathogens standard 29 CFR 1910.1030, as adopted
More informationa. Goggles b. Gowns c. Gloves d. Masks
Scrub In A patient is isolated because of an undetermined respiratory condition. Which PPEs will healthcare professionals need before caring for the patient? a. Goggles b. Gowns c. Gloves d. Masks A patient
More informationFirst Aid Policy. Appletree Treatment Centre
First Aid Policy Appletree Treatment Centre This document has been prepared to provide guidance on the policy and procedures for dealing with First Aid emergences at Appletree Treatment Centre. As a company
More information